TELEmedicine as an Intervention for Sepsis in Emergency Departments

NCT04441944 | Completed

• 1 other identifier: 201901748
• Study Type: observational
• Target: 1,191
• Locations: 1 country
• Sites: 1

Brief Summary

Sepsis is a life-threatening condition that has doubled in incidence over the past decade, and timely aggressive medical intervention has been shown to save lives. Rural sepsis patients have a 38% higher mortality rate, possibly attributable to delays in early sepsis care. Rural emergency department (ED)-based provider-to-provider telemedicine has been proposed to standardize care and support local clinicians in rural hospitals. The goal of this multicenter observational comparative effectiveness study is to measure the association between tele-ED use and clinical outcomes in a cohort of rural sepsis patients.

Conditions

Sepsis

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (1)

• 28-day Hospital-Free Days

  The total number of days in the 28 days after emergency department presentation that a patient is alive and outside the hospital.

  Within 28 days of emergency department presentation

Secondary Outcomes (11)

• Surviving Sepsis Campaign Guideline Adherence

  6 hours after emergency department arrival

• Mortality

  Through hospital discharge, an average of 8 days

• Mechanical Ventilation

  Through hospital discharge, an average of 8 days

• Vasopressors

  Through hospital discharge, an average of 8 days

• New Hemodialysis

  Through hospital discharge, an average of 8 days

Study Arms (2)

Telemedicine Cases

Patients presenting to rural emergency departments who had real-time provider-to-provider telemedicine used to supplement their emergency department care.

Other: Telemedicine

Non-Telemedicine Cases

Patients presenting to rural emergency departments who did not have real-time provider-to-provider telemedicine used to supplement their emergency department care.

Interventions

Telemedicine OTHER

Use of provider-to-provider telemedicine

Telemedicine Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will include all adult (age≥18 years) sepsis patients who presented to a participating rural ED between August 1, 2016 and June 30, 2019. Because of poor sensitivity in diagnosis code-based definitions of sepsis, we elected to use a multi-step definition requiring (1) hospital diagnosis of both infection and organ failure, (2) identification of infection in the ED, (3) presence of organ failure in the ED, and (4) presence of systemic inflammatory response syndrome (SIRS) criteria in the ED. To identify hospital diagnosis of infection and organ failure, we used the Fleischmann-Struzek approximation of sepsis using International Classification of Diseases, 10th edition, Clinical Modification (ICD-10-CM) or an explicit sepsis code (R65.20 or R65.21).

You may qualify if:

• Adults (age 18 years or older)
• Arrive at participating emergency department between August 1, 2016 and June 30, 2019
• Hospital diagnosis of infection and organ failure
• Identification of infection in the emergency department
• Presence of organ failure in the emergency department (SOFA score of at least 2)
• Presence of systemic inflammatory response syndrome (SIRS) in the emergency department

You may not qualify if:

• None

Sponsors & Collaborators

• University of Iowa: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (2)

• Mohr NM, Okoro U, Harland KK, Fuller BM, Campbell K, Swanson MB, Wymore C, Faine B, Zepeski A, Parker EA, Mack L, Bell A, DeJong K, Mueller K, Chrischilles E, Carpenter CR, Wallace K, Jones MP, Ward MM. Outcomes Associated With Rural Emergency Department Provider-to-Provider Telehealth for Sepsis Care: A Multicenter Cohort Study. Ann Emerg Med. 2023 Jan;81(1):1-13. doi: 10.1016/j.annemergmed.2022.07.024. Epub 2022 Oct 15.

  PMID: 36253295 DERIVED

• Mohr NM, Harland KK, Okoro UE, Fuller BM, Campbell K, Swanson MB, Simpson SQ, Parker EA, Mack LJ, Bell A, DeJong K, Faine B, Zepeski A, Mueller K, Chrischilles E, Carpenter CR, Jones MP, Ward MM. TELEmedicine as an intervention for sepsis in emergency departments: a multicenter, comparative effectiveness study (TELEvISED Study). J Comp Eff Res. 2021 Feb;10(2):77-91. doi: 10.2217/cer-2020-0141. Epub 2021 Jan 20.

  PMID: 33470848 DERIVED

MeSH Terms

Conditions

Sepsis

Interventions

Telemedicine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Nicholas Mohr, MD, MS

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 17, 2020
• First Posted: June 22, 2020
• Study Start: August 1, 2016
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: November 9, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)